Blurred Vision: Bias in taxpayer-funded research

by Full Measure Staff

Sunday, December 9th 2018

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Today we focus on taxpayer-funded scientific research — secretly crafted behind our backs to come up with particular results. That’s the shocking allegation about a major study on moderate drinking— proposed by the National Institutes of Health, together with scientists from Harvard and Yale. When you hear what really went on behind the scenes, you may ask: if top scientists are doing that—what else are they doing?

There’s ongoing debate over whether any benefits of drinking in moderation outweigh the known risks. To find out for sure— a new, ten-year $100 million dollar government study began signing up test subjects last January. The Moderate Alcohol and Cardiovascular Health trial was sponsored by the National Institute on Alcohol Abuse and Alcoholism, part of the government’s National Institutes of Health, NIH. If the results came out right—it could mean champagne corks popping inside the alcohol industry with big dividends. Moderate drinking could even be promoted as part of a heart healthy diet! That’s where the whole project went off the rails, according to Dr. Michael Carome at the watchdog Public Citizen.

Dr. Michael Carome: It turns out that the alcohol industry, five of the largest alcohol beverage producers are funding the majority of the study. They’re spending nearly $70-million dollars in this study. And it is a direct violation of an NIH policy that prohibits such solicitation of gifts or money from industry.

NIH added $30 million tax dollars to the study, too. But we examined insider emails suggesting the whole project was secretly designed to be little more than free advertising for industries selling beer, wine and spirits.

Carome: It seems that this study is more interested in serving as a marketing tool for the alcohol industry rather than answering important scientific questions that need to be answered and will advance the health of, the population in the US.

The New York Times first exposed the controversy in 2017 prompting an investigation by NIH. Documents now made public reveal jaw-dropping coordination between government officials, scientists— and the industry that stood to benefit if the study had the right results. In 2013, government officials— whose names are redacted by NIH— raise the idea to “Secure funding” for a study "from the alcoholic beverage industry.” That could give “the appearance that we’re soliciting funding, which we’re not allowed to do, and specifically from industry,” countered one official. “We just flat out can’t come out and say that. it’s a screaming red flashing neon light.” In another email: “We absolutely can’t look like we reached out to industry to seek funding.”

But that’s exactly what they do. First, they seem to ignore rules against favoritism by planning a trip to Boston, home of Harvard’s Dr. Kenneth Mukamal, who would later get chosen to lead the research. “I am going to Boston for a brief ‘vacation,’” writes one unnamed government official. “It would be entirely coincidental if I happened to spend a day with some friends who might be in the process of writing a [study] grant application, and if we also just happened to have some ‘hypothetical' discussions about details of such a study.” Pretty soon, Dr. Mukamal is joking with his government colleagues about trying to get a contribution from an alcohol industry contact. "Get your f**ing a* moving. Sound tactful?”*

Later, Dr. Mukamal comments: “Our chances with the brewers and distillers would only go up with buy-in from other sources, including wine, if we can find any.” Government officials discuss connecting with “Heineken,“ European Beer people” and offering European alcohol producers “our full dog-and-pony-show.” They even provide the alcohol industry with tax money: “two small planning grants to bring together a group of experts to determine how best to structure” the study.

Sharyl: Can you explain in simple terms why it's perceived as a conflict for government to solicit funding from the very people that could benefit from the study?

Carome: The results of those studies end up being favorable to the interest of industry. And that's been shown again and again.

In a presentation, Dr. Mukamal told the alcohol industry “One of the important findings will be showing that moderate drinking is safe” Hints of a larger agenda are found in a pitch Doctor Mukalmal and a Yale colleague Dr. John Krystal made— referring to evidence “necessary” “if alcohol is to be recommended as part of a healthy diet.”

In the end, here’s how it worked. NIH and university researchers approached the alcohol industry for funding. Five alcoholic beverage giants promised $67 million. The money was channeled through the nonprofit Foundation for the National Institutes of Health to go to the NIH study, along with $33 million tax dollars. But that’s only half of the story. As NIH was ginning up a study helpful to the alcohol industry it was also killing research that could be detrimental. Like Dr. Michael Siegel’s studies on alcohol marketing and underage drinking.

Michael Siegel: We knew that we were called in specifically because they weren't happy with this line of research.

Dr. Siegel and a colleague had just finished a study critical of alcohol marketing, when they had a shocking encounter with Dr. George Koob— director of the NIH Institute of Alcohol Abuse.

Siegel: The director essentially called us into his office to tell us that he would not be funding this research anymore. We might as well not submit a grant. We tried to make the scientific argument, explaining why this was very important research. He basically spouted off what I would consider to be alcohol industry talking points. Then finally, he just turned to us, and he said, "I don't f****** care." He said, "It doesn't matter to me.”

Sharyl: When he said that, and you're there trying to make a scientific presentation, what were you thinking?

Michael Siegel: Well, first of all, I was so shocked to hear that, that language and that attitude, that I couldn't believe I was talking to the director of our National Alcohol Institute that's supposed to study alcohol. That was just shocking to me. In fact, after the meeting, my colleague and I, we went down to the cafeteria below the institute, and we kind of asked each other, "Did he actually just say that?” They hatched the idea to file a Freedom of Information Act request to see if internal government emails would explain Dr. Koob’s allegedly hostile attitude.

Sharyl: Did you get any documents that shed light on it?

Michael Siegel: So, we did. It turns out that the proverbial smoking gun was there in the documents that we received. It was an email Dr. Koob sent, making a promise to an alcohol industry representative.

“Sam: For the record. This will NOT happen again... I will NOT be funding this kind of work under my tenure.”

Siegel: Essentially, the Alcohol Institute was making a promise to the alcohol industry that they don't have to worry. This research won't be done again. They won't be funding any research on alcohol marketing. That really, it kind of completed the circle, completed the picture for us of really what was going on there.

But we did sit down with Sarah Longwell of the American Beverage Institute, a trade association.

Sharyl: Looks like government researchers came to them and said, "If you give us a lot of money, we'll kick in some taxpayer money and come out with a study that will probably benefit you."

Longwell: It is clear that this was a problem with the way that the government went about pursuing funding for the research. This was not a problem on the industry side. It was absolutely with the government and the way that they violated their own guidelines around solicitation.

The worst part, she says, is the bad behavior tainted a study on moderate drinking that really needs to be done. As we were reporting this story, NIH finished the investigation of its controversial research project concluding: It had major flaws, “Early and frequent engagement with industry representatives calls into question the impartiality of the process” and competitive advantage and funding were unfairly steered to Dr. Mukamal.

Years in the making— the study has been halted for good. In the aftermath, a giant bureaucratic hangover —and questions as to why no public action has been taken against researchers and government officials involved.

Carome: I think it shows that all too often we have some officials within the National Institutes of Health who are willing to cut ethical corners, uh, and engage in unacceptable conduct. It reflects perhaps a culture from the highest levels of the NIH that allows this type of unethical conduct to flourish.

The government estimates it spent $4 million of your tax dollars on the costs of the cancelled alcohol study.